{"id":453395,"date":"2021-03-09T07:03:16","date_gmt":"2021-03-09T12:03:16","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=453395"},"modified":"2021-03-09T07:03:16","modified_gmt":"2021-03-09T12:03:16","slug":"gamida-cell-reports-full-year-2020-financial-results-and-provides-company-update","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/gamida-cell-reports-full-year-2020-financial-results-and-provides-company-update\/","title":{"rendered":"Gamida Cell Reports Full Year 2020 Financial Results and Provides Company Update"},"content":{"rendered":"

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Gamida Cell Reports Full Year 2020 Financial Results and Provides Company Update<\/b><\/p>\n

\u2013 Primary and secondary endpoints were met, key exploratory endpoints supported clinical benefit in Phase 3 study of omidubicel in patients with hematologic malignancies; BLA submission anticipated in fourth quarter of 2021-<\/i><\/p>\n

\u2014 Omidubicel commercial preparation underway, including the creation of Gamida Cell Assist, to support potential launch \u2014<\/i><\/p>\n

\u2013 GDA-201 demonstrated significant clinical activity in Phase 1 study of patients with non-Hodgkin lymphoma, with multiple complete responses observed; Phase 1\/2 clinical trial planned with IND submission anticipated in the second half of 2021\u2014<\/i><\/p>\n

\u2013 Strengthened financial position with sale of $75M ordinary shares in December 2020 and $75M exchangeable senior notes in February 2021; sufficient liquidity to fund the company\u2019s operations into the second half of 2022 \u2014<\/i><\/p>\n

\u2013 Company to host conference call at 8:30 a.m. ET today \u2013<\/i><\/p>\n

BOSTON–(BUSINESS WIRE<\/a>)–Gamida Cell Ltd.<\/a> (Nasdaq: GMDA), an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases, today reported financial results for the year and quarter ended December 31, 2020. The company also highlighted progress with omidubicel<\/a>, an advanced cell therapy in Phase 3 clinical development as a potentially life-saving treatment option for patients in need of bone marrow transplant, and GDA-201<\/a>, a natural killer (NK) cell immunotherapy in Phase 1 development in patients with non-Hodgkin lymphoma (NHL).\n<\/p>\n

\n\u201cIt has been a significant year for Gamida Cell, marked by a number of important achievements that have brought us closer to developing cures for blood cancers and serious hematologic diseases. Omidubicel, an advanced cell therapy that has met all primary, secondary and exploratory endpoints in our Phase 3 study in patients with hematological malignancies, represents a potentially transformative treatment option. The data we presented in 2020, demonstrating the clinical benefit of omidubicel, position us to submit our first BLA for omidubicel in the fourth quarter of 2021,\u201d said Julian Adams, Ph.D., chief executive officer of Gamida Cell. \u201cWe remain focused on both the BLA submission and preparing for potential commercial readiness, with the announcement of Gamida Cell Assist, a program designed to focus on patient access and a positive omidubicel experience for the patient and the transplant team. We are diligently working to bring omidubicel to patients as soon as possible.\u201d\n<\/p>\n

\n\u201cWe believe our NAM-based cell expansion technology has potential for NK cell expansion and we are developing GDA-201, an NK-cell immunotherapy for the treatment of hematologic and solid tumors in combination with antibody therapies. This year, we made meaningful progress with GDA-201, which has demonstrated impressive early results in patients with heavily pre-treated NHL in a Phase 1 investigator-sponsored study. Following these results, we plan to submit an IND to the FDA in the second half of 2021 and initiate a Phase 1\/2 study,\u201d Dr. Adams continued.\n<\/p>\n

Omidubicel, an investigational advanced cell therapy for allogeneic bone marrow transplant<\/b><\/p>\n

\nDuring the year, Gamida Cell made significant progress to advance its Phase 3 product candidate omidubicel, which is the first cell therapy for bone marrow transplant to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and which has the potential to be the first FDA-approved engineered cell therapy which can be used as a bone marrow transplant graft. The company presented primary, secondary and exploratory endpoints from the company\u2019s international, multi-center, randomized Phase 3 study of omidubicel demonstrating its clinical benefit as a treatment option for patients in need of a bone marrow transplant.\n<\/p>\n

In May<\/a>, Gamida Cell reported that the phase 3 study of omidubicel achieved its primary endpoint, demonstrating a statistically significant reduction in time to neutrophil engraftment, a key milestone in recovery from a bone marrow transplant. It was shown that the median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p<0.001). The Phase 3 study was designed to evaluate the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing a bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant.\n<\/p>\n

\nThe Phase 3 study additionally met key secondary endpoints related to platelet engraftment, infections and hospitalization, all significant clinical measures in bone marrow transplant, as reported in October 2020<\/a>. The prespecified secondary endpoints, analyzed in all randomized patients (intent-to-treat), were the proportion of patients who achieved platelet engraftment by day 42, the proportion of patients with Grade 2 or Grade 3 bacterial or invasive fungal infections in the first 100 days following transplant, and the number of days alive and out of the hospital in the first 100 days following transplant. All three secondary endpoints demonstrated a statistically significant improvement among patients who were randomized to omidubicel compared to the comparator group.\n<\/p>\n

Recently<\/a>, the results of the company\u2019s Phase 3 study of omidubicel were presented at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research. The data from the study relating to exploratory endpoints also supported the clinical benefit demonstrated by the study\u2019s primary and secondary endpoints. Safety results were also presented, showing no significant difference between the two patient groups related to grade III\/IV acute GvHD (14 percent for omidubicel, 21 percent for the comparator) or all grades chronic GvHD at one year (35 percent for omidubicel, 29 percent for the comparator). Transplants with umbilical cord blood, the comparator, have been historically shown to result in low incidence of GvHD in relation to other graft sources, and in this study, omidubicel demonstrated a similar GvHD profile. The rate of infection was significantly reduced for patients randomized to omidubicel, with the cumulative incidence of first grade 2 or grade 3 bacterial or invasive fungal infection for patients randomized to omidubicel of 37 percent, compared to 57 percent for the comparator (p = 0.027). Additionally, the study demonstrated a reduction in the incidence of viral infections. Non-relapse mortality was 11 percent for patients randomized to omidubicel and 24 percent for patients randomized to the comparator (p=0.09). Overall survival at one year following transplant was 73 percent for patients randomized to omidubicel and 62 percent for patients randomized to control (p=0.16).When considering the patient experience following transplant, faster hematopoietic recovery, fewer bacterial and viral infections and fewer days in hospital are all meaningful results and represent potentially important advancements in care.\n<\/p>\n

Additional omidubicel highlights:<\/i><\/p>\n